Metformin Hydrochloride
- Product NDC
- 68788-8600
- 11-digit product format
- 687888600
- Labeler code
- 68788
- Product ID
- 68788-8600_0fbf57d6-3509-45ad-af35-d476b02273dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA209882
- Marketing category
- ANDA
- Marketing start
- 2024-03-08
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 786Z46389E | METFORMIN HYDROCHLORIDE | 1115-70-4 | METFORMIN HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8600-1 | 68788860001 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8600-1) | 2024-03-08 | No | No | Historical |
| 68788-8600-3 | 68788860003 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8600-3) | 2024-03-08 | No | No | Historical |
| 68788-8600-6 | 68788860006 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8600-6) | 2024-03-08 | No | No | Historical |
| 68788-8600-7 | 68788860007 | 180 TABLET, FILM COATED in 1 BOTTLE (68788-8600-7) | 2024-03-08 | No | No | Historical |
| 68788-8600-8 | 68788860008 | 120 TABLET, FILM COATED in 1 BOTTLE (68788-8600-8) | 2024-03-08 | No | No | Historical |
| 68788-8600-9 | 68788860009 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8600-9) | 2024-03-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Metformin Hydrochloride | Preferred Pharmaceuticals Inc. | 2025-08-06 | HUMAN PRESCRIPTION DRUG LABEL | 2 |